Cirrhosis Clinical Trial
Official title:
Safety and Efficacy of Low-dose Terlipressin Delivered by Continuous Intravenous Infusion in Patients With Cirrhosis and Ascites Refractory to, or Intolerant of, Diuretic Therapy, Requiring Large Volume Paracentesis
Verified date | April 2019 |
Source | BioVie Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients with refractory ascites.
Status | Completed |
Enrollment | 6 |
Est. completion date | April 25, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients with cirrhosis and refractory ascites who required 3 or more large volume (4 liters and more) paracenteses in the previous 60 days Exclusion Criteria: - Ascites with causes other than cirrhosis such as nephrogenic ascites or malignant ascites due to peritoneal carcinomatosis - Total bilirubin > 5 mg/dL - Blood clotting International normalized ratio (INR) > 2.5 - Serum creatinine > 2.0 mg/dL - Current or recent (within 3 months of consent) renal dialysis - Hepatic encephalopathy grade 3 or 4 - Superimposed acute liver failure/injury due to factors other than alcoholic hepatitis, including acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom [Amanita] poisoning) - Current or recent treatment (within 7 days) with octreotide, midodrine, vasopressin, dopamine or other vasopressors - Respiratory failure requiring positive airway pressure devices or intubation - SIRS/sepsis episode in the previous 28 days from consent - Episode of spontaneous bacterial peritonitis or gastrointestinal hemorrhage within 28 days of consent - Ongoing documented or suspected infection - Severe cardiovascular disease that are contraindication to terlipressin therapy such as advanced arteriosclerosis, arrhythmia, coronary insufficiency or uncontrolled hypertension - Findings suggestive of organic renal disease (severe proteinuria/hematuria, or abnormal renal ultrasound suggestive of obstructive or other renal pathology) - Severe comorbidity that in the opinion of the Investigator would affect short-term prognosis and/or disallow safe participation in the trial (such as for example, severe anemia or pancytopenia, advanced neoplasia, hepatocellular carcinoma [confirmed with serum alpha1-fetoprotein testing], severe chronic obstructive pulmonary disease or asthma) - Alcoholics who have not been abstinent for the past 6 months - Transjugular intrahepatic portosystemic shunt or other surgical shunt - For female patients: Confirmed pregnancy - Known allergy or hypersensitivity to terlipressin - Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of consent. |
Country | Name | City | State |
---|---|---|---|
United States | Hunter Holmes McGuire VA Medical Center | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
BioVie Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites | Rate of treatment emergent adverse events assessed by physical examination and laboratory safety | 28 day treatment period and 28 day post-treatment | |
Primary | Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites | Serial sampling for determination of Terlipressin concentration and metabolite 8-lysine vasopressin in plasma at steady state (Css) | 7 day treatment | |
Secondary | Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin | Comparison of pre-treatment and post-treatment incidence of therapeutic paracentesis and change in volume of ascites removed | 28 day post-treatment |
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